The FDA unloaded on Neurofield Inc. for misbranding of its products, which are only approved as class II biofeedback devices, as neurostimulation and electroencephalogram (EEG) signal processing devices. The warning letter called on “Neurofield to cease any activities that result in the adulteration or misbranding of the Neurofield X3000/X3000 Plus, Neurofield Q21, Neurofield64 and Neurofield EEG.”
The list of FDA warning letters in recent months has conspicuous in its absence of letters to device makers, but that trend has reversed with three warnings posted March 8, including a warning letter to Cardioquip LLC.
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
Some U.S. FDA warning letters are mostly about documentation, but the key consideration in the widely publicized Dec. 9 FDA warning letter to Dublin-based Medtronic plc seems to be whether Medtronic had a proper understanding of the risk created by malfunctioning infusion pump retainer rings. That difference of opinion regarding risk took a significant bite out of the company’s shares and boosted the fortunes of its rivals in the diabetes space, a cautionary tale regarding the hazards associated with a failure to understand how the FDA sees the risk of device malfunction. The FDA had reported in October 2021 a pair of recalls of Medtronic’s Minimed insulin pumps, although one of the issues cited was related to cybersecurity concerns. The two recalls affected nearly half a million units combined, and could have significantly affect access for some patients.
Device makers have historically struggled to maintain adequate procedures for corrective and preventive action (CAPA) and complaint handling (CH), and two warning letters posted to the FDA website suggest these are still sore spots. Invacare Corp., of Elyria, Ohio, and Smiths Medical ASD Inc., of Minneapolis, were both cited for CAPA and CH deficiencies.
The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage.
The COVID-19 pandemic may have been largely responsible for the lower volume of enforcement activities against device makers in 2020, but the volume of these activities seems to be ramping up in 2021. Recently, the FDA posted a large batch of warning letters to device makers while the U.S. Department of Justice (DoJ) announced two new enforcement actions, including a $27 million fine to the operators of durable medical equipment distributorships for kickbacks, part of a growing set of signals that enforcement is back in vogue in the U.S.
The FDA issued a June 10 warning letter to Innova Medical Group Inc. in connection with the company’s rapid antigen tests for the SARS-CoV-2 virus, an action that accompanies a class I recall and a safety communication.
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